Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Double Spike, Ref ASC1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
This recall has been terminated (originally issued June 11, 2018).
- Company
- Cardinal Health 200, Llc
- Recall Initiated
- June 11, 2018
- Terminated
- August 17, 2020
- Recall Number
- Z-2487-2018
- Quantity
- A total of 63,020 valves were distributed. Specific product quantities were not provided.
- Firm Location
- Waukegan, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The suction valve may not close properly which could cause continuous suction.
Distribution
Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherlands, Singapore, and United Kingdom.
Lot / Code Info
Lot numbers 11742, 41742, 41746, 41752, 41751, 41761, 41762, 41753, 41763, 41765, 41754, 41756, 41759, 41755, 41757, and 41758.
Root Cause
Device Design
Action Taken
The recalling firm issued letters dated 6/11/2018 via FedEx Next Day Priority Mail requesting return of the product.